Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607913
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BCCMA Recovery of Aged Muscle After Disuse Atrophy REMEDY Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength EMPHASIS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPHASIS
Brief Summary:
The aging Veteran population has more frequent inpatient hospitalization than non-Veterans In addition older Veterans have an inability to fully recover muscle mass and function after hospital-acquired weakness The problem of hospital-acquired weakness is greatly increased in at-risk Veteran populations such as those with chronic kidney disease CKD The purpose of this collaborative study involving Denver and Baltimore VAMC sites is to improve health through the detection and rehabilitation management of hospital-acquired weakness in those with CKD The study goals include identifying and monitoring the optimal muscle assessment sites in clinical settings examining how muscle health impacts length of hospital stay and physical resilience and determining how home-based and supervised exercise comparatively addresses post-hospitalization physical resilience using performance tests and Veteran feedback
Detailed Description:
This condition known as disuse muscle atrophy poses a substantial challenge to the health and well-being of individuals particular those hospitalized To tackle this problem the project focuses on a specific group of individuals particularly vulnerable to this issues Veterans with chronic kidney disease CKD This disease affects a substantial population of over 500000 Veterans leading to a progressive decline in mobility unfavorable changes in lean body mass and heightened hospitalization rates To comprehensively address this concern the project indents to develop and implement assessment and intervention strategies tailored to the target cohorts needs By concentrating on Veterans with CKD the project seeks to generate approaches that can be widely applied to address muscle atrophy among individuals with similar conditions To achieve this the project twill commence by establishing a baseline cohort of Veterans with Stage 3 and 4 CKD at two distinct Veterans Affairs sites located in Denver and Baltimore Upon enrollment the Veterans muscles health will be assessed encompassing various dimensions such as strength lean muscle mass muscle composition mobility and intrinsic capacity This comprehensive evaluation will provide a snapshot of their pre-hospitalization muscle health Subsequently the enrolled Veterans will be closely monitored for at least two years The projects approach involves conducting regular assessments of their muscle health every six months Additionally the participating Veterans will provide information about their strength and functional status every quarter facilitated through a smartphone application A particular noteworthy aspect of the project is its inclusion of a pragmatic rehabilitation intervention trail Veterans who experience hospitalization during the study will have the opportunity to participate in this trial They will be assigned to either a supervised flywheel strengthening exercise group or receive usual care over 16 weeks This intervention trial aims to assess the effective ness of targeted exercise in mitigating the effects of disuse muscle atrophy post-hospitalization The overarching design of the project encompasses three main objectives
Aim 1 Identify effective muscle assessment sites for disuse muscle atrophy Aim 2 Assess if standardized intrinsic capacity and physical resilience assessments predict hospital outcomes The investigators anticipate that physical resilience scores will improve hospitalization and strength outcomes predictions
Aim 3 Evaluate a supervised flywheel exercise program against usual care Both groups are expected to improve with the supervised group have better results
Aim 1 Identify effective muscle assessment sites for disuse muscle atrophy Aim 2 Assess if standardized intrinsic capacity and physical resilience assessments predict hospital outcomes The investigators anticipate that physical resilience scores will improve hospitalization and strength outcomes predictions
Aim 3 Evaluate a supervised flywheel exercise program against usual care Both groups are expected to improve with the supervised group have better results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None